⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Bevacizumab, Pemetrexed Disodium, and Cisplatin or Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Bevacizumab, Pemetrexed Disodium, and Cisplatin or Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).

Official Title: Bevacizumab, Pemetrexed and Cisplatin, or Erlotinib and Bevacizumab for Advanced Non-Squamous NSCLC Stratified by EGFR Mutation Status. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).

Study ID: NCT01116219

Conditions

Lung Cancer

Study Description

Brief Summary: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bevacizumab given together with pemetrexed disodium and cisplatin is more effective than erlotinib hydrochloride given together with bevacizumab in treating patients with non-small cell lung cancer. PURPOSE: This phase II trial is studying giving bevacizumab together with pemetrexed disodium and cisplatin to see how well it works compared with giving erlotinib hydrochloride together with bevacizumab in treating patients with stage IV non-small cell lung cancer.

Detailed Description: OBJECTIVES: Primary * To demonstrate that tailored therapy, according to tumor histology and EGFR-mutation status, and the introduction of novel drug combinations in the frontline treatment of patients with stage IV non-squamous non-small cell lung cancer, is promising for further investigation. Secondary * To prospectively explore molecular markers of clinical outcomes. OUTLINE: This is a multicenter study. Patients are stratified according to EGFR(epidermal growth factor receptor)-mutation status (mutated vs wildtype). Patients are assigned to 1 of 2 groups. * mutEGFR (mutated epidermal growth factor receptor) group: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. * wtEGFR (wildtype epidermal growth factor receptor) group cohort 1: * Induction chemotherapy: Patients receive bevacizumab IV over 30-90 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Maintenance therapy: Patients without progressive disease receive bevacizumab IV over 30-90 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression. Blood and tissue specimens are collected for EGFR and molecular markers analysis, including gene expression, mutation, and pharmacogenomic analyses. After completion of study treatment, patients are followed every 3 months. * wtEGFR (wildtype epidermal growth factor receptor) group cohort 2: * Induction chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes, and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Maintenance therapy: Patients without progressive disease receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression. Blood and tissue specimens are collected for EGFR and molecular markers analysis, including gene expression, mutation, and pharmacogenomic analyses. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 129 evaluable patients (77 in cohort 1 and 52 in cohort 2) with wtEGFR status and 20 patients with mutEGFR status will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Kantonsspital Aarau, Aarau, , Switzerland

Kantonsspital Baden, Baden, , Switzerland

Saint Claraspital AG, Basel, , Switzerland

Clinical Cancer Research Center at University Hospital Basel, Basel, , Switzerland

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni, Bellinzona, , Switzerland

Inselspital Bern, Bern, , Switzerland

Spitalzentrum Biel, Biel, , Switzerland

Kantonsspital Bruderholz, Bruderholz, , Switzerland

Kantonsspital Graubuenden, Chur, , Switzerland

Kantonsspital Freiburg, Freiburg, , Switzerland

Hopital Cantonal Universitaire de Geneve, Geneva, , Switzerland

Centre Pluridisciplinaire d' Oncologie, Lausanne, , Switzerland

Kantonsspital Liestal, Liestal, , Switzerland

Kantonsspital Luzern, Luzerne, , Switzerland

Kantonsspital Olten, Olten, , Switzerland

Kantonsspital - St. Gallen, St. Gallen, , Switzerland

Regionalspital, Thun, , Switzerland

Spital Uster, Uster, , Switzerland

Kantonsspital Winterthur, Winterthur, , Switzerland

UniversitaetsSpital Zuerich, Zurich, , Switzerland

City Hospital Triemli, Zurich, , Switzerland

Onkozentrum Hirslanden, Zürich, , Switzerland

Contact Details

Name: Oliver Gautschi, MD

Affiliation: Luzerner Kantonsspital

Role: STUDY_CHAIR

Name: Adrian Ochsenbein, MD

Affiliation: Insel Gruppe AG, University Hospital Bern

Role: PRINCIPAL_INVESTIGATOR

Name: Nicolas Mach, MD

Affiliation: Hopital Cantonal Universitaire de Geneve HUG

Role: PRINCIPAL_INVESTIGATOR

Name: Sacha Rothschild, MD

Affiliation: University Hospital, Basel, Switzerland

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: